• “Indian Medical Device Contract Manufacturing: Trends & Opportunities”, by Mr. Manoj Bhardwaj : Managing Director, SMC Ltd., Bangalore.

• “Blood is not ketchup! Biocompatible Plastics for Medical Devices” by Mr. Sanjay Chotalia : Manager - Technical Sales & Marketing, Covestro (India) Private Limited, Thane, Maharashtra.

• “Opportunities in Medical Textiles Industries” by Dr. Ketan Kumar Vadodaria : Head, Medical Textiles, Coimbatore.

• “What Are Investors Looking For In The MedTech Sector” by Dr. Atul Sardana : Chairman, Alfa Corpuscles Pvt. Ltd., New Delhi.

• "Bio-medical Applications of Plasma Technology" by Dr. Nirav Jamnapara : Scientist, Facilitation Center for Industrial Plasma Technologies, Institute for Plasma Research, Gandhinagar, Gujarat.

• “Styrenics solution for Infusion system, Fluid delivery, Respiratory & Drug device” by Mr. Partha Mohapatra : Lead Healthcare (India) & Technical Support, Styrolution ABS (India) Ltd, India

Session Chairman : Dr. Hemant Desai: Vice President – Operations, Makcur Laboratories, Ahmedabad.

• “Importance of Packaging Material & Sealing; Sterility Monitoring, Preserving & Validation of Sterilization Process” by Mr. Tim Galekop: TiGaMed Consulting, Belgium.

• “EU Clinical Explanation Reports (CER) and Literature Review for Medical Devices”, By Dr. Ashok Thakkar : Head, Clinical Research, Meril Life Sciences Pvt. Ltd., Vapi. &
  Mr. Siddharth Jain : CEO and Chief Regulatory Advisor, Symbiorph Clinical Trialogy, Ahmedabad.

• “Voluntary Certification Scheme for Medical Device Industries”, By Dr. Jaishree Kasliwal : Quality Council Of India (QCI).

• Dr. T. S. Kumaravel : Founder Chairman, GLR Laboratories Pvt. Ltd., Chennai.

• Dr. S.S. Murugan : Managing Director, GLR Laboratories Pvt. Ltd., Chennai.

• Mr. Jayavanth Kamath : Founder & Principal Consultant, Caliber Assurance Services, Bangalore.

• Mr. Ashish Bhutada : CEO & Managing Director, Health Mantra India Pvt. Ltd., Bangalore

• Mr. Deepak Dave : Vice President, Medical Surgical and Healthcare Industries Trade Association, Ashutosh Export International, Mumbai.

Biocompatibility (ISO 10993) Training, February 13, 2016 at Ahmedabad, India

Workshop On Classification, Grouping And Biocompatibility of Medical Devices.

Workshop on Biocompatibility - ISO 10993. Will include various Lectures on Classification, Grouping and Biocompatibility, Testing of Medical Devices as well as hands on Training. End of the day with Conclusion and issue of Certificates.

Session Co-ordinator: Mr. Sanjay Shah, Managing Director, Unikal Consultants, Ahmedabad.

Faculty: Dr. S. S. Murugan, PhD, Managing Director, and Experts from GLR Laboratories Pvt Ltd, Chennai.

The Biocompatibility Workshop will be conducted by GLR Laboratories Pvt .Ltd., Chennai is conducting a one day for the benefit of medical devices manufacturers.

Biocompatibility testing (ISO10993) is not just a box ticking exercise, but a crucial part of the risk management process (ISO 14971) and ensures the safety of medical devices. Biological Evaluation of Medical Devices is often not well understood and typically falls upon QA Manager to comply with its requirements. This hands-on training course will help participants understand biocompatibility requirements for their medical devices and develop approaches to go about testing their products. It should be noted that not all testing are required to determine the biological safety of medical devices. Depending on the nature of the materials and combinations, a literature review and report may be the only justification required to save cost and time on performing unnecessary testing. This course will help you decide if testing is appropriate, and help with researching to generate data for justifications to support a biologically safe device. Attendance certificate will be provided at the end of the training.

Who should attend

1. QA managers in medical device manufacturers
2. Regulatory affair personnel
3. Senior management
4. Design engineers

Course outcome

1. Good understanding of ISO 10993
2. Understanding of required Biocompatibility tests
3. How to plan and undertake a biological evaluation of a medical device
4. When to perform the test, and when not to test
5. How to interpret and understand results

For conference venue on day-2, please check at the reception desk for room nos. for each track on February 12, 2016 at the time of registration.

• Entrepreneurial Opportunities in Medical Devices by Dr. Prashant Jha: Fellowship Director, School Of BioDesign, All India Institute Of Medical Sciences, India.

• Career Opportunities for Medical Device Software Development by Mr. Shinto Joseph: Director, LDRA Technology Pvt. Ltd. Bangalore.

• Career Opportunities in Medical Device Start- up Companies by Mr. Ashish Bhutada: CEO & Managing Director, Health Mantra India Pvt. Ltd., Bangalore.

The Sahajanand Laser Technology - SUSHRUTA Innovation Award (SIA) will be held, to recognize and appreciate students with innovative ideas and concepts having wider applicability to the society for development of Medical Technology products. A jury compromising of experts in the medical device industry and medical professionals will analyze/examine the idea for scientific merit, innovation and commercialization potential.

Moderator & Session Chairman : Dr. Rajesh C. Shah : President, Gujarat Chapter, Associations of Surgeons of India, Consultant Surgeon, A- Prof. Surgery & Medicolegal Expert, Sheth V. S. General Hospital & Smt. N. H. L. Muni. Medical College, Ahmedabad.

• Mr. Tim Galekop : TiGaMed Consulting, Belgium.

• Mr. Sumit Marwah : CEO & Director, Dispoline India Private Limited, Dispoline Healthcare Private Limited i2i Consulting, Deccan Crest, Management Consultant & Entrepreneur.

• Dr. J. L. Meena : State Quality Assurance Medical Officer, Commissioner of Health, Govt. of Gujarat, Gandhinagar.

• Dr. Mahesh Patel : Quality & Patient Safety Officer, Apollo Hospitals International Limited, Ahmedabad

• Safe Point India on Injection Safety & Infection Safety by Expert Speaker of Safe Point India.